Warning Letter – Multidata Systems Intl. Decision Support System

Multidata Systems Intl. Corp. 7/16/98 Decision Support Systems (DSS) for Radiation Support device

1. Failure of management with executive responsibility to appoint a member of management to establish authority over and responsibility for (a) ensuring that quality system requirements are effectively established and effectively maintained, and (b) reporting on the performance of the quality system to management with executive responsibility for review, as required by 21 CFR 820.20(b)(3)(i) & (ii).
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) for the Decision Support System as required by 21 CFR 820.100.

3. Failure to define, document, and implement procedures for quality audits as required by 21 CFR 820.22.

4. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. The Multidata Standard Operating Procedure Re: Software Chance Order (SCO), updated September 30, 1997, is incomplete in that it implies various levels of effort in review, control testing and validation of a software modification which are linked to the severity classification of the software change, and does not identify or describe the activities, tasks, etc., or their associated documentation and completion criteria, which are to be conducted at each level of effort,
b. There is no plan which describes or references the activities, tasks, procedures and responsibilities associated with the implementation of the “Make MLC conventions configurable” enhancement for the DSS per SCO #19069807, dated on or after June 1, 1998,

c. There is no identification or listing of the required design inputs and their sources, procedures to be followed, or indication of approval to proceed with this design change to the DSS,

d. There is no documentation that a formal design review has been conducted, or is planned, for the “Handling MLC Conventions in
DSS” enhancement to the DSS software (SCO #19069807, dated on or after June 1, 1998),

e. There are no written procedures addressing the validation tasks to be performed for new or changed software,

f. There is no risk analysis associated with SCO #19069807 (“Make MLC conventions configurable”), or documentation of a planned risk analysis, or justification that a risk analysis is not necessary,

g. There is no design transfer procedure for the DSS software device, and
h. There are no written procedures which define the format and systematic design reviews which are to be conducted for software changes.

5. Failure to establish and maintain procedures for verifying the device design, failure to ensure that design verification confirms that the design output meets the design input requirements, as required by 21 CFR 820.30(f). For example:

a. There are no written procedures addressing the verification tasks to be performed for new or changed software (i.e. complexity analyses, code inspections, unit coverage analyses),

b. There is no written test plan covering the testing of the changes in DSS software per SCO #19069807, dated on or after June 1, 1998. There is a Product Test Report dated June 23, 1998, but it does not include or reference documentation of the specific test inputs and the actual test results, and

c. There is no documentation of regression analysis or regression testing, or plans for such analyses and tests, associated with the DSS design change implemented with SCO #19069807, dated on or after June 1, 1998. The Multidata Standard Operating Procedure, dated May 10, 1996, Re: Guidelines for Engineering & Testing of Software Change indicates regression analysis and regression testing are to be performed as part of the Software Change Test Methodology.

7. The modifications to be made to the _____ and _____ are not specified.
b. The Multidata Standard Operating Procedure, dated May 10, 1996, Re: Guidelines for Engineering & Testing of Software Change does not identify design outputs to be created or revised for a software change, or their acceptance criteria, and
c. There is no documentation of the review and approval of the Multidata Internal Memo dated June 15, 1998, titled Handling MLC Conventions in DSS, which contains the specified design changes to implement SCO #19069807, dated on or after June 1, 1998.

7. Failure to establish and maintain procedures that ensure the existence of a mechanism for addressing incomplete, ambiguous, or conflicting requirements; failure to ensure that design input requirements are documented, reviewed, and approved by a designated individual(s), as required by 21 CFR 820.30(c). For example:

a. There is no documentation that the design inputs to SCO #19069807, dated on or after June 1, 1998, (“Make MLC conventions connfigurable”) have been reviewed and approved, and

b. The Multidata Standard Operation Procedure, dated May 10, 1996, Re: Guidelines for Engineering & Testing of Software Change lacks a mechanism for addressing incomplete, ambiguous or conflicting requirements.

8. Failure to maintain a device master record (DMR) to contain information as required by 21 CFR 820.181 that is prepared and approved in accordance with 21 CFR 820.40.
9. Failure to validate the _____ as required by 21 CFR 820.70(i).

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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